# K021654: Reprocessed Compression Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Feb 5, 2003 after 261 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100909: Reprocessed Compression Sleeves (2010), 0 descendants of its own

## Indications for use
Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Source page: https://510kreport.com/device/K021654
Methodology: https://510kreport.com/methodology